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Biomarkers and Sustainable Innovation in Cardiovascular Drug Development: Lessons from Near and Far Afield

  • Vascular Biology (RS Rosenson, Section Editor)
  • Published:
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Abstract

Future innovative therapies targeting cardiovascular disease (CVD) have the potential to improve health outcomes and to contain rising healthcare costs. Unsustainable increases in the size, cost and duration of clinical trial programs necessary for regulatory approval, however, threaten the entire innovation enterprise. Rising costs for clinical trials are due in large part to increasing demands for hard cardiovascular clinical endpoints as measures of therapeutic efficacy. The development and validation of predictive and surrogate biomarkers, as laboratory or other objective measures predictive or reflective of clinical endpoints, are an important part of the solution to this challenge. This review will discuss insights applicable to CVD derived from the use of predictive biomarkers in oncologic drug development, the evolving role of high density lipoprotein (HDL) in CVD drug development and the impact biomarkers and surrogates have on the continued investment from multiple societal sources critical for innovative CVD drug discovery and development.

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Conflict of Interest

Russell M. Medford declares that he has no conflicts of interest.

T. Forcht Dagi is a board member and has stock options with Axela Biosciences, consultancy for and has stock/stock options with Syngile, Inc, and is a paid consultant and has travel/accommodations covered or reimbursed by Broadview, and by Masimo, Inc.

Robert S. Rosenson is a consult to Abbott, Daiichi Sankyo, Kowa, LipoScience, and Sanofi-Aventis, has grants/grants pending with Sanofi-Aventis, received honoraria from Kowa, received royalties from UpToDate Medicine and has stock/stock options with LipoScience.

Margaret K. Offerman declares that she has no conflicts of interest.

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Authors and Affiliations

  1. The Salutramed Group, Inc., Atlanta, GA, USA

    Russell M. Medford, T. Forcht Dagi & Margaret K. Offermann

  2. The Division of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA

    T. Forcht Dagi

  3. The School of Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast, Belfast, Northern Ireland, UK

    T. Forcht Dagi

  4. HLM Venture Partners, Boston, MA, USA

    T. Forcht Dagi

  5. Cardiometabolic Disorders, Mount Sinai Heart, New York, NY, USA

    Robert S. Rosenson

  6. Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA

    Robert S. Rosenson

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  1. Russell M. Medford
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Correspondence to Russell M. Medford.

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This article is part of the Topical Collection on Vascular Biology

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Medford, R.M., Dagi, T.F., Rosenson, R.S. et al. Biomarkers and Sustainable Innovation in Cardiovascular Drug Development: Lessons from Near and Far Afield. Curr Atheroscler Rep 15, 321 (2013). https://doi.org/10.1007/s11883-013-0321-0

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